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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: NOBEL BIOCARE AB GÖTEBORG NOBELREPLACE CC PMC NP 3.5X8MM; ENDOSSEOUS DENTAL IMPLANT
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NOBEL BIOCARE AB GÖTEBORG NOBELREPLACE CC PMC NP 3.5X8MM; ENDOSSEOUS DENTAL IMPLANT Back to Search Results
Catalog Number 37284
Medical Device Problem Code Fracture (1260)
Health Effect - Clinical Code No Clinical Signs, Symptoms or Conditions (4582)
Date of Event 10/27/2024
Type of Reportable Event Serious Injury
Event or Problem Description
Component fractured.
 
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Brand Name
NOBELREPLACE CC PMC NP 3.5X8MM
Common Device Name
ENDOSSEOUS DENTAL IMPLANT
Manufacturer (Section D)
NOBEL BIOCARE AB GÖTEBORG
bohusgatan 15
göteborg 41139
SW  41139
MDR Report Key22450315
Report Number2027971-2025-073838
Device Sequence Number8217895
Product Code DZE
UDI-Device Identifier07332747073645
UDI-Public(01)07332747073645(10)13039678(17)211113
Combination Product (Y/N)N
Initial Reporter CountrySP
Number of Events Summarized1
Summary Report (Y/N)N
Device Implanted Year2017
Device Explanted Year2024
Serviced by Third Party (Y/N)N
Reporter Type Importer
Initial Reporter Occupation Dentist
Type of Report Initial
Report Date (Section F) 07/09/2025
1 Device was Involved in the Event
1 Patient was Involved in the Event
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Operator of Device Health Professional
Device Expiration Date11/13/2021
Device Catalogue Number37284
Device Lot Number13039678
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer05/09/2025
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA? No
Distributor Facility Aware Date04/22/2025
Event Location Outpatient Treatment Facility
Initial Date Received by Manufacturer Not provided
Initial Report FDA Received Date07/08/2025
Is This a Single-Use Device that was
Reprocessed and Reused on a Patient? (Y/N)		 No
Usage of Device A
Patient Sequence Number1
Outcome Attributed to Adverse Event Required Intervention;
Patient Age61 YR
Patient SexFemale
Date Report Sent to FDA07/09/2025
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